Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
ConditionPrimary Biliary Cholangitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGilead Sciences
About this trial
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar alone and placebo, in participants with primary biliary cholangitis (PBC).
The primary objective of this study is to determine whether the combination of seladelpar + cilofexor leads to greater alkaline phosphatase (ALP) reduction than seladelpar alone and describe the safety and tolerability of seladelpar + cilofexor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ALP above 1.0 × the ULN for at least 6 months
Positive antimitochondrial antibody titer (> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
Documented liver biopsy results consistent with PBC
Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for > 6 months prior to screening), or intolerant to UDCA (last dose of UDCA > 90 days prior to screening)
Disqualifiers
Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria.
Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome.
Have previous exposure to seladelpar or cilofexor
Trial design
Design model
Parallel
Treatments tested in this trial
Seladelpar
DrugCapsule administered orally
PTM Seladelpar
DrugCapsule administered orally
Cilofexor Dose B
DrugTablet administered orally
PTM Cilofexor Dose A
DrugTablet administered orally
PTM Cilofexor Dose B
DrugTablet administered orally
Cilofexor Dose A
DrugTablet administered orally
Treatment groups
132 Participants
are divided into 4 treatment groupsGroup A: Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose BExperimental treatment 3 interventions
Group B: SEL 10 mg + CILO Dose A + PTM CILO Dose BExperimental treatment 3 interventions
Group C: SEL 10 mg + PTM CILO Dose A + PTM CILO Dose BActive comparator 3 interventions
Group D: PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose BPlacebo comparator 3 interventions
Trial outcomes
Primary outcomes
1
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
Time frame
Baseline, Week 242
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame
First dose up to 30 days post last dose (up to 318 weeks)3
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame
First dose up to 30 days post last dose (up to 318 weeks)Secondary outcomes
1
Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
Defined as the percentage of participants with ALP \< 1.67 × upper limit of normal (ULN), ALP decrease of ≥ 15%, and total bilirubin ≤ 1 × ULN.
Time frame
Week 242
Proportion of Participants Achieving ALP Normalization at Week 24
ALP Normalization is defined as ALP ≤ 1.0 × ULN.
Time frame
Week 243
Change From Baseline to Week 24 in Weekly Average Pruritus Numerical Rating Scale (NRS)
Time frame
Baseline, Week 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: